***Qualified Person (QP) Batch Certification is mandatory***

Purpose of Role

To perform final QP Batch Certification to ensure all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, and relevant EU, USA, or other regulatory requirements (e.g. Russia, Brazil, Canada).

Key Result Areas

• Ensure cGMP principles and guidelines have been met during manufacturing, packaging and testing.
• Verify all batch documentation meets regulatory authority requirements.
• Review and certify batches according to business shipment schedules.
• Ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements and CE certification requirements are met.
• Ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and checks.
• Ensure planned or unplanned changes in manufacturing or quality control are notified per established reporting systems.
• Ensure manufacturing and testing processes are validated and all necessary checks and tests completed.
• Ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff.

Areas of Impact Affecting the Job

• Releasing non-compliant product can result in patient risk, recalls, investigations and possible prosecution of the QP and the Company.
• Appropriate measures must ensure processes, testing and products comply with licensed requirements.

Planning, Organising and Controlling

• Release batches in line with business schedules where possible.
• Meet all requirements in the Key Result Areas, ensuring validation, checks and notifications are in place before release of any product.

Knowledge, Skills and Abilities

Skills

• Strong communication and teamwork.
• Ability to set and deliver high performance standards related to quality, safety, cost and customer service.

Core Competencies

• Communication
• Influencing

Qualifications and Accreditations

• Degree-level qualification (or equivalent) in science.
• Membership of an appropriate professional body.
• Registered Qualified Person acceptable to the Licensing Authority.
• Significant experience in a senior Quality role; experience as a Quality Leader in a modern pharmaceutical manufacturing environment desirable.